Untangling the Web - 5th Edition by MSF Access Campaign

price

pr ice eligi bility

y n a p Untangling the web of price reductions: m o c co price un trie s a pricing guide for the purchase of ARVs for developing countries e i s r t n u co

reductions redu c tions

1st December 2003 Fifth edition

Table of contents

3 4 4 5 5 7 7 8 9 11

Table of contents General background and objectives Methodology Prices Barriers to accessing price offers The challenges of paediatric formulations Research and development for HIV/AIDS How to use these tables? Practical example: price and eligibility of three products from three different companies in four countries Tables 11 Table 1: Summary of selected pharmaceutical companies’ best ARV price offers for eligible developing countries 11 Table 1a – Nucleoside Reverse Transcriptase Inhibitors (NRTIs) 12 Table 1b – Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) 13 Table 1c – Nucleotide Reverse Transcriptase Inhibitors (NtRTIS) 14 Table 1d – Protease Inhibitors (PIs) 15 Table 1e – Fixed Dose Combinations (FDCs) 16 Table 1f – Combined blisters 17 Table 1g – Paediatric Formulations 18 Table 2: Company ARV offers and restrictions for developing countries, adult and paediatric formulations 18 Table 2a – Nucleoside Reverse Transcriptase Inhibitors (NRTIs) 22 Table 2b – Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) 23 Table 2c – Nucleotide Reverse Transcriptase Inhibitors (NtRTIs) 24 Table 2d – Protease Inhibitors (PIs) 27 Table 2e – Fixed Dose Combinations (FDCs) 29 Table 2f – Selected generic companies’ ARV offers and restrictions for developing countries 30 Annexes 30 Annex 1: Least Developed Countries (LDCs) 30 Annex 2: Human Development Index (HDI) 31 Annex 3: Sub-Saharan countries 31 Annex 4: World Bank low-income countries 31 Annex 5: Company contacts 33 Glossary 35 References

Médecins Sans Frontières • www.accessmed-msf.org • December 2003 • Untangling the Web of Price Reductions • 3

General background and objectives This is the fifth edition of “Untangling the web of price reductions: a pricing guide for the purchase of ARVs for developing countries”, the first edition was published in October 2001[1]. A lack of clear information on pharmaceutical prices on the international market is a significant barrier to improving access to essential medicines in developing countries. The situation is particularly complex in the case of antiretrovirals (ARVs). The data in this guide on ARV prices offered by originator companies and some generic companies in low- and middle-income countries are meant to provide potential buyers with clear and verified data. This information is intended for use by government and non-profit procurement agencies, as well as other bulk purchasers of ARVs, including health facilities and nongovernmental organisations (NGOs). This document includes pricing information on both adult and paediatric formulations, and is meant to be used in tandem with

the pre-qualification report called “Pilot Procurement, Quality and Sourcing Project: Access to HIV/AIDS Drugs and Diagnostics of Acceptable Quality”, a project initiated by WHO and developed in collaboration with other United Nations Organisations (UNAIDS, UNICEF, UNFPA). This prequalification project evaluates pharmaceutical manufacturers and products according to WHO recommended standards of quality and compliance with Good Manufacturing Practices. WHO prequalification is given to specific products produced by specific companies at specific manufacturing sites. It is part of an ongoing process that will expand as the participation of suppliers increases. An updated list of products is regularly posted on the websites of WHO and other UN-collaborating agencies[2]; products on this list are commonly referred to as “WHO prequalified”. This list of “pre-qualified” drugs is an important tool for NGOs and Governments to assist them with drug procurement. In all the tables in this report, prequalified products are indicated in bold and with an asterisk.

This fifth edition provides: • updated information on prices for eligible countries, including both price per unit and price per patient per year for adult and paediatric formulations • updated information and clarifications on the conditions and restrictions applying to these offers • practical examples on how to use this document Not all the products in this document have been pre-qualified by WHO or approved by MSF. Therefore, procurement agencies should follow their own procedures in this respect. Ultimately it is national regulatory authorities that are responsible for approving the use of a given drug from a given manufacturer. Pricing information on other essential drugs and diagnostics used for HIV/AIDS can be found in the 4th edition of the report “Sources and Prices of Selected Medicines and Diagnostics for People Living with HIV/AIDS” June 2003[3]. We have indicated fixed-dose combinations (FDCs) in this report since MSF has found that using these products facilitates program implementation and patient

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compliance. The new edition of WHO Treatment Guidelines specially mentions the usefulness of FDCs in resource-poor settings. Not only are the FDCs advantageous from a medical point of view, but also they are the most affordable option in most cases. The triple FDC D4T/3TC/NVP from two generic manufacturers has recently been pre-qualified by WHO. Methodology In order to obtain accurate information on discounted price offers by both originator and generic companies, firms were contacted and asked to provide information about drug, dosage and pharmaceutical form, price per unit (or daily dose), restrictions that apply to the offers (eligibility), and additional comments. The list of

generic producers included in this report is by no means exhaustive[4]. All generic drugs included in this pricing guide have at least been cleared for marketing in their countries of origin. • All prices are quoted in US dollars and conversions were made on the day the price was received. • All prices were checked and verified by companies. • In table 1, prices are rounded. The exact prices including decimals are in table 2. The annual cost of therapy was calculated according to WHO[5] and Centres for Disease Control and Prevention (CDC)[6] dosing schedules (for those products not recommended in the WHO Guidelines). Prices Since 2000, the international prices of some first-line ARVs have tumbled, due to competition from generic companies, sustained public pressure, discount offers from originator companies, and the

growing political attention paid to the AIDS epidemic. Several major events have played a key role, beginning with a precedent set by Brazil which made a triple drug combination possible at less than US$3000 per patient per year (ppy) in the 90s. Public pressure on the pharmaceutical companies built up over the following years, and in May 2000, five originator firms announced a new partnership, the Accelerating Access Initiative (AAI). It was the first time that these firms had initiated differential pricing policies for ARVs. In February 2001, the Indian generics firm Cipla shattered the price barrier when it publicly announced that it would sell a triple combination for US$350 ppy. Due to this type of competition, prices continue to fall. Today, a triple combination (FDC) costs US$270/year.

Other initiatives, like the Andean initiative or more recently the Clinton Foundation announcement, are also bringing down prices. The Andean initiative, through regional negotiations with pharmaceutical companies, has fixed a reference price for all the countries in the region. The Clinton Foundation has brokered a deal with generic makers which brings fixed dose triple combinations down to US$140 per year. These initiatives although not widely available will affect some specific countries. Prices cited in this document are the best international offers made by companies, but delivery conditions must be taken into account. Both generics and originator companies impose restrictions on their offers, but only originator companies apply geographical limits (a differential pricing policy). Barriers to accessing price offers

The graph on page 6 shows the evolution of prices since August 2001 for WHO recommended first line regimens.

Information is presented in a table format to facilitate the comparison of price offers. This format highlights the lack of standardisation among

different companies on eligibility and terms and conditions. For instance, some companies use UNCTAD (Least Developed Countries) criteria, others UNDP, some others World Bank classification (Human Development Index). It should be noted that some developing countries have been excluded by some or all companies. It means that some countries cannot benefit from any differential price at all. In regions like Eastern Europe, only 24% of the countries can benefit from the best price and in Latin America and Caribbean, only 31%.* Even when a specific country is eligible, all purchasers within the country may not be eligible for reduced prices. The conditions of some offers are sometimes restrictive and sometimes only NGOs, Governments and national and international institutions are eligible. Delivery conditions also affect prices, as in many cases clearance fees, importation taxes (when they exist) and transport are not included.

* We refer to best possible prices (those in Table 1), but we note that some companies (Roche and Merck & Co. Inc.) offer also a second differential price. The conditions for these second prices are less restrictive and can be found in Table 2.

Médecins Sans Frontières • www.accessmed-msf.org • December 2003 • Untangling the Web of Price Reductions • 5

Evolution of prices since August 2001 of WHO recommended first line regimens

D4T/3TC/NVP D4T/3TC+EFV ZDV/3TC/NVP ZDV/3TC+EFV

Triple FDC

cost of treatment (US$/year)

1200US$ 1000US$ 800US$ 600US$ 400US$ 200US$ 0

Aug 01

Oct 01

Dec 01

Feb 02

Apr 02

Jun 02

Aug 02

Oct 02

Dec 02

Feb 03

Apr 03

Jun 03

Aug 03

Oct 03

Dec 03

The chart above shows that efavirenz containing regimens are more expensive. In addition there is no EFV containing triple FDC available on the market yet.

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Another barrier to accessing the best price is the availability of the drug in a country. Since ARVs are not always registered and/or available in “selected countries”, many offers from pharmaceutical companies may remain “theoretical”. In addition, prices cited in this report may not correspond to enduser prices (prices to patients), since other factors may increase prices such as national distribution and handling charges, mark-up rates, and national and/or import and sales taxes. Patents and use of flexibilities existing in TRIPS and reinforced by the Doha Declaration on TRIPS and Public Health (such as compulsory licence, government use) can also influence the availability of medicines in a country. Information concerning the patent status of ARVs which differs between companies is not included in the

present analysis. Some information about the patent status of ARVs in some countries can be found in “Patent Situation of HIV/AIDS related drugs in 80 countries”, WHO/UNAIDS, 2000[7] and the MSF report “Drug patents under the spotlight: sharing practical knowledge about pharmaceutical patents”, May 2003[8]. It is important to mention that geographical limitations do not concern FDCs, since most of them are produced by generic companies. The challenge of paediatric formulations There is an urgent need to develop fixed-dose combinations for use in children. Protocols for paediatric patients are complicated and expensive. The prices of paediatric formulations remain higher than those for adults, especially for second line treatments. For

example, a paediatric patient would have to pay US$ 283.20 per year for a d4T+3TC+NVP regimen using three different syrups while an adult will take the same regimen in a FDC for US$ 270. For a second line (ZDV+ddI+NFV), the cost of treatment for a child would be US$ 3191/year while for the adult it would be US$ 1096 per year. In this case, none of them would be able to use a FDC.** Research and development (R&D) for HIV/AIDS Paediatric formulations are not the only area where there is a need for R&D. For both adults and children, new drugs and diagnostic tools, as well as vaccines are needed for HIV/AIDS. Pharmaceutical investment in research and development largely responds to market potential in the industrialised world. We need to ensure that R&D also responds to the needs of patients in developing and least developed countries.

** For these examples we used the case of a 10 kg, 3 year old patient in an MSF project, following the protocols of this project. When comparing prices we used the best possible price for every molecule.

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How to use these tables

Prices: Table 1 shows the best price offers of some generic and originator producers for each antiretroviral drug, (including fixed-dose combinations), regardless of the conditions to get these prices. Figures within brackets indicate price in US$ per unit (capsules, tablets etc.). Prices per patient per year have been calculated according to daily doses given either in WHO guidelines or in CDC guidelines (for those products not recommended in WHO guidelines). Prices can be used as a reference with suppliers. Originator companies set different prices depending on the country. Which country is eligible and the conditions to benefit these differential prices are specified in Table 2. Restrictions: Table 2 shows restrictions imposed by generic (2f ) and originator (2a to 2e) companies and provides indications about the availability of offers in individual countries. There is no uniform differential pricing system and each originator company sets geographical limits to their programmes. Generic companies have no geographical limits but may have quantity related conditions. Please refer to Annexes 1, 2 and 4 for updated country classification by UNCTAD (Least Developed Countries), UNDP (Human Development Index) and World Bank (low-income and lower-middle-income economies). Annex 3 lists sub-Saharan countries. This document is also available in French and Spanish on www.accessmed-msf.org The following table (pages 9 and 10) summarises prices and eligibility conditions of three products from three different companies in four countries.

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Practical examples: Price and eligibility of three products from three different companies in four countries COMPANIES and OFFERS

Merck Stocrin® (efavirenz) 600 mg Prices and eligibility (countries): – US$ 346.75/year for Low Human Development Index (HDI) countries plus medium HDI countries with adult HIV prevalence of 1% or greater[9] – US$ 767/year for medium HDI countries with adult HIV prevalence less than 1%[10] Delivery of goods: CIF (9) Eligibility (bodies): Governments, international organizations, NGOs, private sector organizations (e.g. employers, hospitals and insurers). Merck and Co., Inc. does not rule out supplying ARVs to patients through retail pharmacies.

Ranbaxy Triviro LNS® (d4T/3TC/NVP) 40 mg+150 mg+200 mg Prices and eligibility (countries): US$ 270/year. All countries are eligible Delivery of goods: FOB Delhi/Mumbai (India) Prices apply to orders for a minimum of 1.5 million units. Different prices are offered for smaller quantities (500 000 or 1 million units). Eligibility (bodies): NGOs and Governments or Programs supported by them.

Roche Viracept® (nelfinavir) 250 mg Prices and eligibility (countries): – CHF 1229 /year =US$ 887/year for all countries in sub-Saharan Africa and all UN defined Least Developed Countries – CHF 4055/year=US$ 2927/year in Low income countries and lower middle income countries – as classified by the World Bank. Delivery of goods: Terms and conditions: Effective date 1st March 2003. FCA Basel (CH), CAD (Cash Against Documents) 30 days at sight. Minimum order and delivery amount per shipment is CHF 10,000 (US$ 7218) Eligibility (bodies): Governments, Non Profit Institutional Providers of HIV care, NGOs.

MALAWI It is a LDC1 Low HDI2 Low Income Economy3 It is a Sub-Saharan country4 Adult HIV prevalence 15%5

Is Malawi an eligible country? Yes, for the first price Am I an eligible purchaser? Yes, if Government, international organization, NGO or private sector organization How much will Stocrin 600 cost in my country? US$ 346.75/year Will delivery conditions increase this price? Yes, I have to add clearance fees + importation taxes (when existing) + local transport

Is Malawi an eligible country? Yes Am I an eligible purchaser? Yes, if an NGO, Government or a program supported by them How much will Triviro LNS cost in my country? US$ 270/year if I order more than 1.5 million units Will delivery conditions increase this price? Yes, I have to add clearance fees + importation taxes (when existing) + local and international transport

Is Malawi an eligible country? Yes, for the first price Am I an eligible purchaser? Yes, if Government, Non Profit Institutional Providers of HIV care or NGO How much will Viracept cost in my country? US$ 887/year Will delivery conditions increase this price? Yes, I have to add clearance fees + importation taxes (when existing) + local and international transport

CAMBODIA It is a LDC1 Medium HDI2 Low Income Economy3 It is not a Sub-Saharan country4

Is Cambodia an eligible country? Yes, for the first price Am I an eligible purchaser? Yes, if Government, international organization, NGO, private sector organization

Is Cambodia an eligible country? Yes Am I an eligible purchaser? Yes, if an NGO, Government or a program supported by them

Is Cambodia an eligible country? Yes, for the first price Am I an eligible purchaser? Yes, if Government, Non Profit Institutional Providers of HIV care or NGO

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Adult HIV prevalence 2.7%5

How much will Stocrin 600 cost in my country? US$ 346.75/year Will delivery conditions increase this price? Yes, I have to add clearance fees + importation taxes (when existing) + local transport

How much will Triviro LNS cost in my country? US$ 270/year if I order more than 1.5 million units Will delivery conditions increase this price? Yes, I have to add clearance fees + importation taxes (when existing) + local and international transport

How much will Viracept cost in my country? US$ 887/year Will delivery conditions increase this price? Yes, I have to add clearance fees + importation taxes (when existing) + local and international transport

UKRAINE It is not a LDC1 Medium HDI2 Lower-Middle Income Economy3 It is not a Sub-Saharan country4 Adult HIV prevalence 1%5

Is the Ukraine an eligible country? Yes, for the first price Am I an eligible purchaser? Yes, if Government, international organization, NGO or private sector organization How much will Stocrin 600 cost in my country? US$ 346.75/year Will delivery conditions increase this price? Yes, I have to add clearance fees + importation taxes (when existing) + local transport

Is the Ukraine an eligible country? Yes Am I an eligible purchaser? Yes, if an NGO, Government or a program supported by them How much will Triviro LNS cost in my country? US$ 270/year if I order more than 1.5 million units Will delivery conditions increase this price? Yes, I have to add clearance fees + importation taxes (when existing) + local and international transport

Is the Ukraine an eligible country? Yes, for the second price Am I an eligible purchaser? Yes, if Government, Non Profit Institutional Providers of HIV care or NGO How much will Viracept cost in my country? US$ 2927/year Will delivery conditions increase this price? Yes, I have to add clearance fees + importation taxes (when existing) + local and international transport

COLOMBIA It is not a LDC1 Medium HDI2 Lower-Middle Income Economy3 It is not a Sub-Saharan country4 Adult HIV prevalence o.4%5

Is Colombia an eligible country? Yes, for the second price Am I an eligible purchaser? Yes, if Government, international organization, NGO or private sector organization How much will Stocrin 600 cost in my country? US$ 767/year Will delivery conditions increase this price? Yes, I have to add clearance fees + importation taxes (when existing) + local transport

Is Colombia an eligible country? Yes Am I an eligible purchaser? Yes, if an NGO, Government or a program supported by them How much will Triviro LNS cost in my country? US$ 270/year if I order more than 1.5 million units Will delivery conditions increase this price? Yes, I have to add clearance fees + importation taxes (when existing) + local and international transport

Is Colombia an eligible country? Yes, for the second price Am I an eligible purchaser? Yes, if Government, Non Profit Institutional Providers of HIV care or NGO How much will Viracept cost in my country? US$ 2927/year Will delivery conditions increase this price? Yes, I have to add clearance fees + importation taxes (when existing) + local and international transport

1 LDC: Least Developed Country according to UNCTAD classification. See annex 1 of this document for full list of LDCs. 2 HDI: Human Development Index according to UNDP classification. Countries are classified on Low HDI, Medium HDI and High HDI (this last one does not concern differential prices). Low and Middle HDI lists of countries are in the Annex 2 of this document. 3 World Bank classification depends on income. Countries are classified as Low Income Economies, Middle-Low Income Economies, Middle Income Economies and Upper. Middle Income Economies (these last two do not concern differential prices). Low Income Economy and Lower-Middle Income Economy countries are listed in the Annex 4 of this document. 4 See annex 3 of this document for full list of sub-Saharan African countries published by the World Bank. 5 Merck prices depend on Adult HIV prevalence, which is periodically reviewed by UNAIDS (www.who.int/emc-hiv/fact_sheets/All_countries.html).

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Table 1: Summary of selected pharmaceutical companies’ best ARV price offers for eligible developing countries Table 1a – Nucleoside Reverse Transcriptase Inhibitors (NRTIs)

lamivudine (3TC)

stavudine (d4T)

zidovudine (ZDV or AZT)

150

300

31 (0.043/unit)

140 (0.192/unit)

NRTI (Abbreviation)

abacavir (ABC)

didanosine (ddI)

All prices are in US$. Prices are given both for a yearly adult dose and by unit.

Strength (mg)

300

100 (§)

Daily dose

For details on eligibility and offer restrictions for countries and institutions, please refer to table 2a and 2f.

Aurobindo (India)

197 (0.135/unit)

BMS (US)

310* (0.212/unit)

Not applicable

292 (0.20/unit)

88* 270 (0.741/unit) (0.12/unit)

Products on the WHO list of “Pilot Procurement, Quality and Sourcing Project: Access to HIV/AIDS drugs and diagnostics of acceptable quality” (Eleventh edition, 1st December 2003)[2] are in bold and have an asterisk * next to the price. Always check website for most recently updated list. Best prices are in bold & underlined. Incoterms vary according to manufacturers.[9] Annual cost is calculated according to the daily doses given in the WHO “Scaling-up Antiretroviral Therapy in Resource Limited Settings: Guidelines for a Public Health Approach” (June 2002)[5] and/or the “Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents”[6], by the Panel on Clinical Practices for the Treatment of HIV, July 2003.

(§) BMS sells ddI (didanosine) in other doses (per mg price remains the same)

Cipla (India)

821 (1.125/unit)

didanosine (ddI) EC 400 1

66 (0.090/unit)

48* 55* (0.066/unit) (0.075/unit) 47 102 53 (0.280/unit) (0.065/unit) (0.072/unit)

292* (0.400/unit)

Combinopharm (Spain) 163 (0.223/unit)

650 (0.445/unit)

GPO (India)

57 73 (0.078/unit) (0.100/unit)

69* Not (0.095/unit) applicable

GSK (UK)

887* (1.215/unit)

Hetero (##) (India)

1325 (1.815/unit)

185 (0.127/unit)

Ranbaxy (India)

1314 (1.8/unit)

415 (0.284/unit)

Strides (India)

160* (0.22/unit)

65* (0.089/unit) 335 (0.917/unit)

277 (0.380/unit) 211* (0.290/unit)

31* (0.042/unit)

175* (0.240/unit)

100* 100 (0.137/unit) (0.274unit)

36 47 (0.049/unit) (0.064/unit)

180* (0.246/unit)

97 (0.133/unit)

35 46 (0.048/unit) (0.063/unit)

(##) Hetero prices have not been updated since May 2003 as they did not provide the requested information for this edition. Médecins Sans Frontières • www.accessmed-msf.org • December 2003 • Untangling the Web of Price Reductions • 11

Table 1b – Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs)

NNRTI (Abbreviation)

efavirenz (EFV)

nevirapine (NVP)

All prices are in US$. Prices are given both for a yearly adult dose and by unit.

Strength (mg)

200

600

200

Daily dose

For details on eligibility and offer restrictions for countries and institutions, please refer to table 2b and 2f.

Aurobindo (India)

438 (0.400/unit)

Cipla (India)

Annual cost is calculated according to the daily doses given in the WHO “Scaling-up Antiretroviral Therapy in Resource Limited Settings: Guidelines for a Public Health Approach” (June 2002)[5] and/or the “Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents”[6], by the Panel on Clinical Practices for the Treatment of HIV, July 2003.

112 (0.153/unit)

Boehringer-Ingelheim (Germany)

438* (0.600/unit) 462 (0.422/unit)

462 (1.267/unit)

GPO (Thailand)

124* (0.17/unit) 244 (0.334/unit)

Hetero (##) (India)

548 (0.500/unit)

Merck (US)

500 (0.457/unit)(†)

347 (0.950/unit)(†)

Ranbaxy (India)

427 (0.39/unit)

427 (1.17/unit)

Strides (India)

105* (0.144/unit)

166* (0.228/unit) 162 (0.222/unit)

(†) Prices given in this table are for Low Human Development Index (HDI) countries plus medium HDI countries with adult HIV prevalence of 1% or greater. Table 2b gives prices for medium HDI countries with adult HIV prevalence of less than 1%.[10] (##) Hetero prices have not been updated since May 2003 as they did not provide the requested information for this edition.

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Table 1c - Nucleotide Reverse Transcriptase Inhibitors (NtRTIs)

The price is in US$. Price is given both for a yearly adult dose and by unit. For details on eligibility and offer restrictions for countries and institutions, please refer to table 2c.

NtRTI (Abbreviation)

tenofovir (TDF)

Strength (mg)

300 mg

Daily dose

Gilead (US)

475 (1.30/unit)

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Table 1d - Protease Inhibitors (PIs) All prices are in US$. Prices are given both for a yearly adult dose and by unit. For details on eligibility and offer restrictions for countries and institutions, please refer to table 2d and 2f.

PI (Abbreviation)

indinavir (IDV)

nelfinavir (NFV)

ritonavir (r)

saquinavir hard gel capsules (SQV hgc)

Strength (mg)

400

250

100

200

Daily dose

4 (**)

10 (***)

2 (§)

10 (#)

Abbott (US)

83* (0.114/unit)

Aurobindo (India)

393 (0.269/unit)

1533 (0.420/unit)

336 (0.460/unit)

Cipla (India)

365 (0.25/unit)

1789 (0.49/unit)

394 (0.54/unit)

Hetero (##) (India)

387* (0.265/unit)

1500 (0.411/unit)

219 (0.300/unit)

Merck (US)

400 (0.274/unit)

Ranbaxy (India)

467* (0.320/unit)

Roche (Switzerland) Strides (India)

887* 0.243/unit(†)

1336 (0.366/unit)

927* 0.254/unit(†)

463 (0.317/unit)

(**) The daily dose referred to is 800mg IDV twice daily with ritonavir 100mg twice daily as booster. The prescribing information given by the manufacturer is 800mg three times daily (***) The daily dose referred to is 1250 mg twice daily although the dosage of 9 tablets (3 tablets three times a day) can also be used. (§) The daily dose referred to is 100mg twice daily, for use as booster medication. This dose is not indicated in the manufacturer’s label. (#) Saquinavir should be used in combination with low-dose ritonavir as saquinavir/ritonavir 1000mg/100mg twice daily (†) Prices given in this table are for sub-Saharan Africa and Least Developed Countries as UN defined. See table 2d for prices for Low Income and Lower Middle Income Countries, as classified by the World Bank. (##) Hetero prices have not been updated since May 2003 as they did not provide the requested information for this edition.

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Table 1e – Fixed Dose Combinations (FDCs) All prices are in US$. Prices are given both for a yearly adult dose and by unit. For details on eligibility and offer restrictions for countries and institutions, please refer to table 2e and 2f. Combination

lopinavir+ 3TC+d4T ritonavir (LPV/r)

3TC+d4T

ZDV+3TC

ZDV+3TC+NVP ABC+3TC+ZDV

3TC+d4T+NVP

Strength (mg)

133.3 + 33.3

150 + 30

150 + 40

300+150

300 + 150 + 200

300+150+300

150 +30+200

150 +40+200

Therapeutic class(es)

1PI

2NRTI

2NRTI + 1NNRTI

3NRTI

2NRTI + 1NNRTI

Daily dose

Abbott (US)

500* (0.228/unit)

Aurobindo (India)

204 (0.280/unit)

Cipla (India)

131 (0.18/unit)

146 (0.20/unit)

197* (0.27/unit)

GPO (Thailand)

407 (0.558/unit)

GSK (US)

237** (0.325/unit)

Hetero (##) (India)

3TC+d4T+NVP

3833 (1.750/unit)

365 (0.50/unit)

255 (0.35/unit)

270* (0.37/unit)

325 (0.445/unit)

358 (0.490/unit)

1241* (1.700/unit)

135 (0.185/unit)

141 (0.193/unit)

276 (0.378/unit)

383 (0.525/unit)

1648 (2.258/unit)

281 (0.385/unit)

286 (0.392/unit)

Ranbaxy (India)

125 (0.171/unit)

135 (0.185/unit)

265** (0.363/unit)

416 (0.570/unit)

1579 (2.163/unit)

285* (0.390/unit)

292* (0.400/unit)

Strides (India)

122 (0.167/unit)

133 (0.182/unit)

261 (0.358/unit)

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Table 1f – Combined blisters The three drugs are presented in the same blister. Drugs must be taken once a day. Price is in US$. Price is given both for a yearly adult dose and by unit.

1NNRTI + 2NRTI

EFV+3TC+ddl (EC)

Strength (mg)

600 + 300 + 250

600 + 300 + 400

Daily dose Cipla

1+1+1 931 (2.55/unit)

For details on eligibility, offer restrictions for countries and institutions, Incoterm and ways to apply, please refer to table 2f.

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1+1+1 949 (2.60/unit)

Table 1g – Paediatric Formulations For details on eligibility and offer restrictions for countries and institutions, please refer to table 2. ARV

Company

Strength/Dosage form

Presentation

Price per pack

Additional information

abacavir

GSK

20mg/ml oral solution

240ml

US$ 31.32**

didanosine

BMS

lamivudine

GSK

powder: 2g of active principle sold as a bottle for re-constitution with water and with antacids 100mg/ml oral solution

Cost per day as indicated by the manufacturer: US$ 2.90 Sold in local currency in Southern Africa – Rand and East Africa - shillings. Sold in Euro to West African countries.

240ml

US$ 6.73*

stavudine

Cipla GPO BMS

100mg/ml oral solution 100mg/ml syrup 1mg/ml powder for syrup

100ml 60ml 200ml

US$ 2.00* US$ 1.54 US$ 9.50

BMS

15mg capsules

Not available*

BMS

20mg capsules

GPO GPO GPO GPO GSK

15mg capsules 20mg capsules 1mg/ml dry syrup 5mg/ml dry syrup 10mg/ml syrup

Blister pack of 56 Blister pack of 56 Box of 60 Box of 60 60ml 60ml 200ml

Cipla GPO Combinopharm Merck BI Cipla

50mg/5ml oral solution 10mg/ml syrup 50mg/5ml oral solution 50mg capsules 10mg/ml suspension 50mg/5ml suspension

GPO Roche Abbott Abbott

10mg/ml oral suspension 50mg/g, powder for suspension 80mg/ml oral solution 20mg + 80mg/ml oral solution

zidovudine

efavirenz nevirapine

nelfinavir ritonavir ritonavir + lopinavir

US$ 14.74

100ml 60ml/200ml 200ml Bottle of 30 240ml 100ml & 25ml (PMTCT) 60ml 144g 450ml(5x90ml) 300ml(5x60ml)

Cost per day as indicated by manufacturer. (average paediatric dosage based on 25kg average weight): US$ 0.62.

Sold in local currency in Southern Africa Rand and East Africa - shillings. Sold in Euro to West African countries.

US$ 5.25* US$ US$ US$ US$ US$

3.50 4.20 0.65 0.97 7.10*

US$ 1.53* US$ 1.28/3.85 US$ 4.20 US$ 3.47 US$ 17.50* US$ 2.45 & US$ 2.00 (PMTCT) US$ 0.92 US$ 35* (**) (/) US$ 41.67* US$ 41.67*

US$ 0.058/capsule. US$ 0.070/capsule.

Cost per day as indicated by manufacturer. (average paediatric dosage based on 25kg average weight): US$ 1.58.

US$0.116/unit PMTCT dose: 25ml.

(**) On 19 September 2003, 1 US$ = 1.38540 CHF. (/) All prices of Roche products are in Swiss francs (CHF). Prices given in this table are for sub-Saharan Africa and Least Developed Countries as UN defined. See table 2c for prices for Low Income and Lower Middle Income Countries, as classified by the World Bank. Products on the WHO list of ‘Pilot Procurement, Quality and Sourcing Project: Access to HIV/AIDS drugs and diagnostics of acceptable quality’ (Eleventh edition, 1st December 2003)[2] are in bold and have an asterisk * next to the price. Always check website for most recently updated list. Best prices are in bold & underlined. Incoterms vary according to manufacturers [9].

Médecins Sans Frontières • www.accessmed-msf.org • December 2003 • Untangling the Web of Price Reductions • 17

Table 2 Originator companies – ARV offers and restrictions for developing countries, adult and paediatric formulations Table 2a Nucleoside Reverse Transcriptase Inhibitors (NRTIs) Product

Company

Eligibility (countries)

Eligibility (body)

Price in US$

Additional comments

abacavir 300mg tablets (Ziagen®)

GlaxoSmithKline

Least Developed Countries (LDCs) plus sub-Saharan Africa.

Governments, aid organizations, charities, international, UN agencies, other not-for-profit organizations and international purchase funds such as the Global Fund to fight AIDS, TB and Malaria.

US$ 887/year 1.215/unit

CIP Supply Agreement required (For NGOs requiring less than 10 patient packs per month, this requirement may be waived).

All projects fully financed by the Global Fund to fight AIDS, TB and Malaria.

(For middle income developing countries public sector prices negotiated on a case-by-case basis or bilaterally or through the AAI).

The manufacturer recommends that ‘prescribers must ensure that patients are fully informed regarding hypersensitivity reaction to abacavir. Patients developing signs or symptoms must contact their doctor immediately for advice.’

In sub-Saharan Africa employers there who offer HIV/AIDS care and treatment directly to their staff through workplace clinics or similar arrangements are also eligible. All organizations must supply the preferentially priced products on a not for profit basis.

GlaxoSmithKline abacavir 20mg/ml oral solution 240ml (Ziagen®)

Least Developed Countries (LDCs) plus sub-Saharan Africa. All projects fully financed by the Global Fund to fight AIDS, TB and Malaria.

(For middle income developing countries public sector prices negotiated on a case-by-case basis or bilaterally or through the AAI).

Governments, aid organizations, charities, international, UN agencies, other not-for-profit organizations and international purchase funds such as the Global Fund to fight AIDS, TB and Malaria. In sub-Saharan Africa employers there who offer HIV/AIDS care and treatment directly to their staff through workplace clinics or similar arrangements are also eligible. All organizations must supply the preferentially priced products on a not for profit basis.

18 • Untangling the Web of Price Reductions • December 2003 • www.accessmed-msf.org • Médecins Sans Frontières

Delivery of goods[9]

US$ 31.32 per bottle

CIP Supply Agreement required (For NGOs requiring less than 10 patient packs per month, this requirement may be waived). The manufacturer recommends that ‘prescribers must ensure that patients are fully informed regarding hypersensitivity reaction to abacavir. Patients developing signs or symptoms must contact their doctor immediately for advice.’

Product

Company

Eligibility (countries)

Eligibility (body)

Price in US$

didanosine 100mg (Videx®)

Bristol-Myers Squibb Co.

Sub-Saharan Africa.

Both private and public sector organisations that are able to provide effective, sustainable and medically sound care and treatment of HIV/AIDS are eligible.

US$ 310/year US$ 0.212/unit

didanosine powder for oral solution 2g+anti-acid (Videx®)

Bristol Myers Squibb Co,

Both private and public sector organisations that are able to provide effective, sustainable and medically sound care and treatment of HIV/AIDS are eligible.

US$ 14.74 per bottle

Governments, aid organisations, charities, international, UN agencies, other not-for-profit organisations and international purchase funds such as the Global Fund to fight AIDS, TB and Malaria.

US$ 69/year US$ 0.095/unit

(For other developing countries, prices negotiated on a case by case basis through the AAI.)

GlaxoSmithKline lamivudine 150mg tablet (Epivir®)

Sub-Saharan Africa

(For other developing countries, prices negotiated on a case by case basis through the AAI.) LDCs plus sub-Saharan Africa. All projects fully financed by the Global Fund to fight AIDS, TB and Malaria.

(For middle income developing countries public sector prices negotiated on a case-by-case basis or bilaterally or through the AAI.)

In sub-Saharan Africa employers there who offer HIV/AIDS care and treatment directly to their staff through workplace clinics or similar arrangements are also eligible.

Lower tablet dosages prices in line with this offer

Additional comments Delivery of goods[9] DDU to government purchasing entities.

DDU to government purchasing entities. CIP Supply Agreement required (For NGOs requiring less than 10 patient packs per month, this requirement may be waived).

All organisations must supply the preferentially priced products on a not for profit basis.

Médecins Sans Frontières • www.accessmed-msf.org • December 2003 • Untangling the Web of Price Reductions • 19

Product

Company

Eligibility (countries)

Eligibility (body)

Price in US$

Additional comments Delivery of goods[9]

lamivudine 10mg/ml oral solution 240ml (Epivir®)

GlaxoSmithKline

LDCs plus sub-Saharan Africa.

Governments, aid organisations, charities, international, UN agencies, other not-for-profit organisations and international purchase funds such as the Global Fund to fight AIDS, TB and Malaria.

US$ 6.73 per bottle

Supply Agreement CIP required (For NGOs requiring less than 10 patient packs per month, this requirement may be waived).

All projects fully financed by the Global Fund to fight AIDS, TB and Malaria.

(For middle income developing countries public sector prices negotiated on a case-by-case basis or bilaterally or through the AAI.)

In sub-Saharan Africa employers there who offer HIV/AIDS care and treatment directly to their staff through workplace clinics or similar arrangements are also eligible. All organisations must supply the preferentially priced products on a not for profit basis.

stavudine 30mg and 40mg caps (Zerit®)

Bristol-Myers Squibb Co.

Sub-Saharan Africa.

(For other developing countries, prices negotiated on a case by case basis through the AAI.)

Both private and public sector organisations that are able to provide effective, sustainable and medically sound care and treatment of HIV/AIDS are eligible.

20mg: US$ 68.4/year (US$ 0.094/unit)

DDU to government purchasing entities

30mg: US$ 48.25/year (US$ 0.066/unit) 40mg: US$ 54.75/year (US$ 0.075/unit)

stavudine 1mg/ml powder for syrup 200ml (Zerit®)

Bristol-Myers Squibb Co.

Sub-Saharan Africa.

(For other developing countries, prices negotiated on a case by case basis through the AAI.)

Both private and public sector organisations that are able to provide effective, sustainable and medically sound care and treatment of HIV/AIDS are eligible.

20 • Untangling the Web of Price Reductions • December 2003 • www.accessmed-msf.org • Médecins Sans Frontières

US$ 9.50 per bottle

DDU to government purchasing entities

Product

Company

Eligibility (countries)

Eligibility (body)

Price in US$

Additional comments

Delivery of goods[9]

zidovudine 300mg tablets (Retrovir®)

GlaxoSmithKline

LDCs plus sub-Saharan Africa.

Governments, aid organisations, charities, international, UN agencies, other not-for-profit organisations and international purchase funds such as the Global Fund to fight AIDS, TB and Malaria.

US$ 212/year (US$ 0.290/unit)

Supply Agreement required.

CIP

All projects fully financed by the Global Fund to fight AIDS, TB and Malaria.

(For middle income developing countries public sector prices negotiated on a case-by-case basis or bilaterally or through the AAI.)

(For NGOs requiring less than 10 patient packs per month, this requirement may be waived.)

In sub-Saharan Africa, employers there who offer HIV/AIDS care and treatment directly to their staff through workplace clinics or similar arrangements are also eligible. All organisations must supply the preferentially priced products on a not for profit basis.

zidovudine 10mg/ml syrup 200ml (Retrovir®)

GlaxoSmithKline

LDCs plus sub-Saharan Africa. All projects fully financed by the Global Fund to fight AIDS, TB and Malaria.

(For middle income developing countries public sector prices negotiated on a case-by-case basis or bilaterally or through the AAI.)

Governments, aid organisations, charities, international, UN agencies, other not-for-profit organisations and international purchase funds such as the Global Fund to fight AIDS, TB and Malaria. In sub-Saharan Africa, employers there who offer HIV/AIDS care and treatment directly to their staff through workplace clinics or similar arrangements are also eligible.

US$ 7.10 per bottle

Supply Agreement required.

CIP

(For NGOs requiring less than 10 patient packs per month, this requirement may be waived.)

All organisations must supply the preferentially priced products on a not for profit basis.

Médecins Sans Frontières • www.accessmed-msf.org • December 2003 • Untangling the Web of Price Reductions • 21

Table 2b Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs)

Price in US$

Product

Company

Eligibility (countries)

Eligibility (body)

efavirenz (Stocrin®)

Merck & Co., Inc.

Low Human Development Index (HDI) countries plus medium HDI countries with adult HIV prevalence of 1% or greater[10].

600mg tablet: Governments, international organisations, NGOs, private sector US$ 346.75/year (US$ 0.950/unit) organisations (e.g. employers, hospitals and insurers). 200mg capsule: US$ 500/year Merck & Co., Inc. does not rule (US$ 0.457/unit) out supplying ARVs to patients through retail pharmacies. 50mg capsule: US$ 0.116/unit US$ 3.47 per bottle of 30

efavirenz (Stocrin®)

Merck & Co., Inc.

Medium HDI countries with adult HIV prevalence less than 1%[10].

Governments, international 600mg tablet: organisations, NGOs, private sector US$ 767/year organisations (e.g. employers, (US$ 2.10/unit) hospitals and insurers). 200mg capsule: US$ 920/year Merck & Co., Inc. does not rule (US$ 0.840/unit) out supplying ARVs to patients through retail pharmacies. 50mg capsule US$ 0.213 per unit US$ 6.39 per bottle of 30

CIP

nevirapine 200mg tablets (Viramune®)

Boehringer Ingelheim

All World Bank low-income countries and sub-Saharan Africa.

Governments, NGOs and other partners who can guarantee that the programme is run in a responsible manner.

US$ 438/year (US$ 0.600/unit)

CIF

Governments, NGOs and other partners who can guarantee that the programme is run in a responsible manner.

US$ 17.50 per unit

CIF

(Other countries on a case-by-case basis.) nevirapine 10mg/ml suspension 240ml (Viramune®)

Boehringer Ingelheim

All World Bank low-income countries and sub-Saharan Africa.

(Other countries on a case-by-case basis.)

22 • Untangling the Web of Price Reductions • December 2003 • www.accessmed-msf.org • Médecins Sans Frontières

Additional comments

Delivery of goods[9]

Although Romania does not fall under these categories it also benefits from these prices due to a government commitment to a programme of universal access.

CIP

Table 2c Nucleotide Reverse Transcriptase Inhibitors (NtRTIs) Product

Company

Eligibility (countries)

Eligibility (body)

Price in US$

Additional comments

Delivery of goods[9]

tenofovir 300mg (Viread®)

Gilead

53 nations in Africa and 15 other UN-designated ‘least developed’ countries.

Organisations that provide HIV treatment in the 68 countries covered by the Viread Access programme will be able to receive Viread at the access price. Applications will go through a review process.

US$ 475/year (US$ 1.30/unit)

The programmes will be managed through Axios.

FOB

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Table 2d Protease Inhibitors (PIs) Product

Company

indinavir (400mg caps) (Crixivan®)

Merck & Co., Low Human Development Inc. Index (HDI) countries plus medium HDI countries with adult HIV prevalence of 1% or greater[10].

Eligibility (countries)

Eligibility (body)

Price in US$

Additional comments

Governments, international organisations, NGOs, private sector organisations (e.g. employers, hospitals and insurers).

US$ 400/year (US$ 0.274/unit)

Although Romania does CIP not fall under these categories it also benefits from these prices due to a government commitment to a programme of universal access.

US$ 686/year (US$ 0.470/unit)

CIP

Bottle of 270 tablets: CHF 3o0.00 US$ 216.54 US$ 2937/year (US$ 0.802/unit)

Terms and conditions: Effective date 1st March 2003. FCA Basel (Switzerland), CAD (Cash Against Documents) 30 days at sight. Minimum order and delivery amount per shipment is CHF 10,000 (US$ 7218)

Merck & Co., Inc. does not rule out supplying ARVs to patients through retail pharmacies. indinavir (400mg caps) (Crixivan®)

Merck & Co., Medium HDI countries with Inc. adult HIV prevalence less than 1%[10].

Governments, international organisations, NGOs, private sector organisations (e.g. employers, hospitals and insurers).

Delivery of goods[9]

Merck & Co., Inc. does not rule out supplying ARVs to patients through retail pharmacies. nelfinavir 250mg tablets (Viracept®)

Roche

Low income countries and lower middle income countries - as classified by the World Bank.

Governments, Non Profit Institutional Providers of HIV care, NGOs.

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Additional comments

Eligibility (countries)

Eligibility (body)

Price in US$

nelfinavir 250mg Roche tablets (Viracept®)

All countries in sub-Saharan Africa and all UN defined Least Developed Countries.

Governments, Non Profit Institutional Providers of HIV care, NGOs.

Bottle of 270 tablets CHF 90.90 (US$ 65.61) US$ 886.95/year (US$ 0.243/unit)

Terms and conditions: Effective date 1st March 2003. FCA Basel (Switzerland), CAD (Cash Against Documents) 30 days at sight. Minimum order and delivery amount per shipment is CHF 10,000 (US$ 7218)

Roche nelfinavir powder for oral solution 144g 50mg/g (Viracept®)

Low income countries and Lower middle income countries - as classified by the World Bank.

Governments, Non Profit Institutional Providers of HIV care, NGOs.

CHF 55.00 per bottle (US$ 39.70)

Roche nelfinavir powder for oral solution 144g 50mg/g (Viracept®)

All countries in sub-Saharan Africa and all UN defined Least Developed Countries.

Governments, Non Profit Institutional Providers of HIV care, NGOs.

CHF 49.00 per bottle (US$ 35.37)

Terms and conditions: Effective date 1st March 2003. FCA Basel (Switzerland), CAD (Cash Against Documents) 30 days at sight. Minimum order and delivery amount per shipment is CHF 10,000 (US$ 7218)

Product

Company

Delivery of goods[9]

Médecins Sans Frontières • www.accessmed-msf.org • December 2003 • Untangling the Web of Price Reductions • 25

Product

Company

Eligibility (countries)

Eligibility (body)

Price in US$

ritonavir 100mg caps (Norvir®)

Abbott

All African countries and the LDCs outside of Africa.

Governments, NGOs, UN system organisations and other national and international health institutions.

“Booster dose”: US$ 83/year (US$ 0.114/unit)

FOB

ritonavir oral solution 450ml (Norvir®)

Abbott

All African countries and the LDCs outside of Africa.

Governments, NGOs, UN system organisations and other national and international health institutions.

US$ 41.67 per bottle

FOB

saquinavir 200mg hard gel capsules (Invirase®)

Roche

Low income countries and Lower middle income counries - as classified by the World Bank.

Governments, Non Profit Institutional Providers of HIV care, NGOs.

Bottle of 270 capsules: CHF 300.00 (US$ 216.54)

Terms and conditions: Effective date 1st March 2003. FCA Basel (Switzerland), CAD (Cash Against Documents) 30 days at sight. Minimum order and delivery amount per shipment is CHF 10,000 (US$ 7218)

US$ 2927/year (US$ 0.802/unit)

saquinavir 200mg hard gel capsules (Invirase®)

Roche

All countries in sub-Saharan Africa and all UN defined Least Developed Countries.

Governments, Non Profit Institutional Providers of HIV care, NGOs.

Bottle of 270 capsules: CHF 95.40 (US$ 68.57) US$ 927/year (US$ 0.254/unit)

26 • Untangling the Web of Price Reductions • December 2003 • www.accessmed-msf.org • Médecins Sans Frontières

Additional comments

Delivery of goods[9]

Terms and conditions: Effective date 1st March 2003. FCA Basel (Switzerland), CAD (Cash Against Documents) 30 days at sight. Minimum order and delivery amount per shipment is CHF 10,000 (US$ 7218)

Table 2e Fixed Dose Combinations Product

lopinavir/ ritonavir 133.33 + 33.3 mg capsules (Kaletra®) lopinavir/ ritonavir oral solution 300ml (Kaletra®)

Company

Abbott

Additional comments Delivery of goods[9]

Eligibility (countries)

Eligibility (body)

Price in US$

All African countries and the Least Developed Countries (LDCs) outside of Africa.

Governments, NGOs, UN system organisations, and other national and international health institutions.

US$ 500/year (US$ 0.228/unit)

FOB

All African countries and the Least Developed Countries (LDCs) outside of Africa.

Governments, NGOs, UN system organisations, and other national and international health institutions.

US$ 41.67 per bottle

FOB

lamivudine + GlaxoSmithKline LDCs plus sub-Saharan Africa. zidovudine 300mg + All projects fully financed by 150mg tablets the Global Fund to fight AIDS, (Combivir®) TB and Malaria.

(For middle income developing countries public sector prices negotiated on a case-by-case basis bilaterally or through the AAI.)

Governments, aid organisations, charities, US$ 237/year international, UN agencies, other not-for- (US$ 0.325/unit) profit organisations and international purchase funds such as the Global Fund to fight AIDS, TB & Malaria. In sub-Saharan Africa, employers there who offer HIV/AIDS care and treatment directly to their staff through workplace clinics or similar arrangements are also eligible.

Supply Agreement required.

CIP

(For NGOs requiring less than 10 patient packs per month, this requirement may be waived.)

All organisations must supply the preferentially priced products on a not for profit basis.

Médecins Sans Frontières • www.accessmed-msf.org • December 2003 • Untangling the Web of Price Reductions • 27

Product

Company

Eligibility (countries)

abacavir + GlaxoSmithKline LDCs plus sub-Saharan Africa. lamivudine + zidovudine All projects fully financed by 300 + 150 + the Global Fund to fight AIDS, 300mg tablets TB and Malaria. (Trizivir®) (For middle income developing countries public sector prices negotiated on a case-by-case basis bilaterally or through the AAI.

Eligibility (body)

Price in US$

Governments, aid organisations, charities, US$ 1241/year international, UN agencies, other not-for- (US$ 1.700/unit) profit organisations and international purchase funds such as the Global Fund to fight AIDS, TB & Malaria. In sub-Saharan Africa, employers there who offer HIV/AIDS care and treatment directly to their staff through workplace clinics or similar arrangements are also eligible. All organisations must supply the preferentially priced products on a not for profit basis.

28 • Untangling the Web of Price Reductions • December 2003 • www.accessmed-msf.org • Médecins Sans Frontières

Additional comments Delivery of goods[9] Supply Agreement required. (For NGOs requiring less than 10 patients pack per month, this requirement may be waived.) The manufacturer recommends that ‘prescribers must ensure that patients are fully informed regarding hypersensitivity reaction to abacavir. Patients developing signs or symptoms must contact their doctor immediately for advice.’

CIP

Table 2f Selected generic companies’ ARV offers and restrictions for developing countries

Company

Eligibility (countries)

Eligibility (body)

Price in US$

Additional comments

Delivery of goods[9]

Aurobindo

No restriction

NGOs and Governmental Organizations.

See Table 1.

Prices available for at least 1,000,000 units for each product per single shipment.

FOB Hyderabad (India)

Payment by letter of credit. No quantity related conditions. Prices are as per table 1 however for larger quantities the prices are negotiable.

FOB Mumbai (India) or CIF. Freight charges separately on actual.

See Table 1.

Payment by signed letter of credit.

FOB Bangkok (Thailand)

See Table 1.

Prices could be negotiated on individual basis according commercial terms.

FOB Mumbai (India)

Prices given in Table 1 apply to orders for a minimum of 1.5 million units. Different prices are offered for smaller quantities (500 000 or 1 million units).

Signed letter of credit.

FOB Delhi/Mumbai (India)

No restriction.

See Table 1.

Delivery terms 120 days. No minimum order required unless any special labelling is required (standard labelling is in Spanish): order of a complete batch. Pack of 60 or 300 capsules available for ZDV.

FOB Barcelona (Spain)

Governments, non profit institutional providers of HIV treatment, NGO’s.

US$ per pack unit as given in price list.

Payment by signed letter of credit.

FOB Bangalore (India)

Cipla

No restriction

NGOs and Governmental Organizations.

GPO

No restriction

Not-for-profit organizations and governments.

Hetero

No restriction

Private sector, Public sector and NGO’s.

Ranbaxy

No restriction

NGO’s and Governments or Programs supported by them.

Combinopharm

No restriction

Strides

No restriction

See Table 1. For bulk purchases prices are negotiable.

Other generic manufacturers producing ARVs exist but are not included in this summary of offers Médecins Sans Frontières • www.accessmed-msf.org • December 2003 • Untangling the Web of Price Reductions • 29

Annexes

Annex 1: Least Developed Countries (LDCs)

Annex 2: Human Development Index (HDI)

Source: UNCTAD http://www.unctad.org/Templates/Web Flyer.asp?intItemID=2161&lang=1 Forty-nine countries are currently designated least developed countries (LDCs). The list is reviewed every three years.

Source: Human Development Report 2002, Making new technologies work for human development UNDP. For full list of Human Development Index ranking see http://www.undp.org/hdr2003/pdf/pre sskit/HDR03_PKE_HDI.pdf

Afghanistan; Angola; Bangladesh; Benin; Bhutan; Burkina Faso; Burundi; Cambodia; Cape Verde; Central African Republic; Chad; Comoros; Democratic Republic of Congo; Djibouti; Equatorial Guinea; Eritrea; Ethiopia; Gambia; Guinea; Guinea Bissau; Haiti; Kiribati; Lao People’s Democratic Republic; Lesotho; Liberia; Madagascar; Malawi; Maldives; Mali; Mauritania; Mozambique; Myanmar; Nepal; Niger; Rwanda; Samoa; Sao Tome and Principe; Senegal; Sierra Leone; Solomon Islands; Somalia; Sudan; Togo; Tuvalu; Uganda; United Republic of Tanzania; Vanuatu; Yemen; Zambia.

Low human development Angola; Benin; Burkina Faso; Burundi; Cameroon; Central African Republic; Chad; Congo (Dem. Rep. of the); Côte d’Ivoire; Djibouti; Eritrea; Ethiopia; Gambia; Guinea; GuineaBissau; Haiti; Kenya; Madagascar; Malawi; Mali; Mauritania; Mozambique; Nepal; Niger; Nigeria; Pakistan; Rwanda; Senegal; Sierra Leone; Tanzania (U. Rep. of ); Uganda; Yemen; Zambia; Zimbabwe. Medium human development Albania; Algeria; Antigua and Barbuda; Armenia; Azerbaijan; Bangladesh;; Belize; Bhutan; Bolivia; Bosnia and Herzegovina; Botswana; Brazil; Bulgaria; Cambodia; Cape Verde; China; Colombia; Comoros; Congo;; Dominica; Dominican Republic; Ecuador; Egypt; El Salvador; Equatorial Guinea; Fiji; Gabon; Georgia; Ghana; Grenada; Guatemala; Guyana; Honduras; India; Indonesia; Iran (Islamic Rep. of );

30 • Untangling the Web of Price Reductions • December 2003 • www.accessmed-msf.org • Médecins Sans Frontières

Jamaica; Jordan; Kazakhstan;; Kyrgyzstan; Lao People’s Dem.Rep; Lebanon; Lesotho; Libyan Arab Jamahiriya; Macedonia (TFYR); Malaysia; Maldives; Mauritius;; Moldova (Rep. of ); Mongolia; Morocco; Myanmar; Namibia; Nicaragua; Oman; Occupied Palestinian Territories; Panama; Papua New Guinea; Paraguay; Peru; Philippines; Romania; Russian Federation; Saint Lucia; Samoa (Western); São Tomé & Principe; Saudi Arabia; Solomon Islands; South Africa; Sri Lanka; St.Vincent and the Grenadines; Sudan; Suriname; Swaziland; Syrian Arab Republic; Tajikistan; Thailand; Togo; Tunisia; Turkey; Turkmenistan; Ukraine; Uzbekistan; Vanuatu; Venezuela; Viet Nam.

Annex 3: Sub-Saharan countries Source: World Bank (April 2003) http://www.worldbank.org/data/countr yclass/classgroups.htm Angola; Benin; Botswana; Burkina Faso; Burundi; Cameroon; Cape Verde; Central African Republic; Chad; Comoros; Congo (Dem. Rep); Cong (Rep.); Côte d’Ivoire; Equatorial Guinea; Eritrea; Ethiopia; Gabon; Gambia; Ghana; Guinea; GuineaBissau; Kenya; Lesotho; Liberia; Madagascar; Malawi; Mali; Mauritania; Mauritius; Mozambique; Namibia; Niger; Nigeria; Rwanda; São Tomé and Principe; Senegal; Seychelles; Sierra Leone; Somalia; South Africa; Sudan; Swaziland; Tanzania; Togo; Uganda; Zambia; Zimbabwe.

Annex 4: World Bank low-income countries Source: World Bank (September 2003) http://www.worldbank.org/data/countr yclass/classgroups.htm Low-income economies Afghanistan; Angola; Azerbaijan; Bangladesh; Benin; Bhutan; Burkina Faso; Burundi; Cambodia; Cameroon; Central African Republic; Chad; Comoros; Congo (Dem. Rep.), Congo (Rep.); Côte d’Ivoire; Equatorial Guinea; Eritrea; Ethiopia; Gambia; Georgia; Ghana; Guinea; GuineaBissau; Haiti; India; Indonesia; Kenya; Korea, Dem. Rep.; Kyrgyz Republic; Lao PDR; Lesotho; Liberia; Madagascar; Malawi; Mali; Mauritania; Moldova; Mongolia; Mozambique; Myanmar; Nepal; Nicaragua; Niger; Nigeria; Pakistan; Papua New Guinea; Rwanda; São Tomé and Principe; Senegal; Sierra Leone; Solomon Islands; Somalia; Sudan; Tajikistan; Tanzania; TimorLeste; Togo; Uganda; Uzbekistan; Vietnam; Yemen (Rep.), Zambia; Zimbabwe.

Lower-middle-income economies Albania; Algeria; Armenia; Belarus; Bolivia; Bosnia and Herzegovina; Brazil;Bulgaria; Cape Verde; China; Colombia; Cuba; Djibouti; Dominican Republic; Ecuador; Egypt, Arab Rep.; El Salvador; Fiji; Guatemala; Guyana; Honduras; Iran, Islamic Rep.; Iraq; Jamaica; Jordan; Kazakhstan; Kiribati; Macedonia, FYR; Maldives; Marshall Islands; Micronesia, Fed. Sts.; Morocco; Namibia; Paraguay; Peru; Philippines; Romania; Russian Federation; Samoa; Serbia and Montenegro; South Africa; Sri Lanka; St. Vincent and the Grenadines; Suriname; Swaziland; Syrian Arab Republic; Thailand; Tonga; Tunisia; Turkey; Turkmenistan; Ukraine; Vanuatu; West Bank and Gaza. Upper-middle-income economies American Samoa; Antigua and Barbuda; Argentina; Barbados; Belize; Botswana; Chile; Costa Rica; Croatia; Czech Republic; Dominica; Estonia; Gabon; Grenada; Hungary; Isle of Man; Latvia; Lebanon; Libya; Lithuania; Malaysia; Malta; Mauritius; Mayotte; Mexico; Oman; Palau; Panama; Poland; Puerto Rico; Saudi Arabia; Seychelles; Slovak Republic; St. Kitts and Nevis; St. Lucia; Trinidad and Tobago; Uruguay; Venezuela, RB;

Annex 5: Company contacts Abbott: Rob Dintruff Email: rob.dintruff@abbott.com AXIOS International manages the application process and serves as the central contact: The Programme Manager Access to HIV Care Programme AXIOS International P.O. Box 6924 Kampala, Uganda. Tel: +256 75 693 756 Fax:+256 41 543 021 Email: AccesstoHIVCare@axiosint.com Website : www.accesstohivcare.org Aurobindo Pharma Ltd: Mr. Venkateshan Regional Manager - International Business Tel: +91 40 2373 7332 / 5572 5208 (Direct) Or +91 98480 257 64 (Mobile) Fax: +91 40 2374 10 80 Email: venky@aurobindo.com Bristol-Myers Squibb Co: West Africa: information can be obtained from Ms Marie-Astrid Mercier, BMS Access Coordinator in BMS Paris office (marie-astrid.mercier@bms.com)

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East Africa: information can be obtained from BMS main distributor in East Africa M. Mukesh Mehta at Phillips Pharmaceuticals in Nairobi (ppl@phillipspharma.com).

Tel: +91 22 3021397 (Direct) 3095521 3092891 Fax: +91 22 3070013/3070393/3070385 Email: exports@cipla.com and ciplaexp@cipla.com

Southern Africa: information can be obtained from Ms Tamany Geldenhuys in BMS offices in Johannesburg (tamany.geldenhuys@bms.com).

Combinopharm: Ms. Assumpció Giralt Export Manager Combinopharm Tel: + 34 93 48 08 833 Fax: + 34 93 48 08 832 Email: AGiralt@combino-pharm.es

Boehringer Ingelheim: Laurence Phillips (for preferential prices) CD Marketing Prescription Medicines HIV-Specialists/Virologists Phone: + 49 6132 77-2081 Fax: +49 6132 77-3829 Email: phillips@ing.boehringeringelheim.com Hélène Clary (for the Viramune MTCT donation program) Marketing Prescription Medicines CG HIV-Specialists/Virologists Tel: + 49 6132 77-34 36 Fax: + 49 6132 77-38 29 Email: claryh@ing.boehringeringelheim.com Cipla Ltd: Mr. Sanjeev Gupte, General ManagerExports, Cipla Limited and Mr. Shailesh Pednekar Executive-Exports, Cipla Limited

Gilead: Programme Access (primary contact) Gilead Access Program Axios International Plot 1 Pilkington Road 6th Floor Workers House Building P.O. Box 6924 Kampala Uganda Tel: +256-41-340806/7 Fax: +256-41-340642 Email: GileadAccess@axiosint.com Company contact Joe Steele Senior Director, Commercial Development Gilead Sciences 333 Lakeside Drive Foster City California 94404 1-650-522-5740

GlaxoSmithKline: Mr. Jon Pender Director External Relations Global Access Issues Tel: + 44 (0) 20 8047 5489 Fax: + 44 (0) 208 047 6957 Email: jon.d.pender@gsk.com GPO: Mr. Sukhum Virattipong Export Manager Tel: + 662 248 1482, + 662 203 8808 Fax: + 662 248 1488 Email: sukhum@health.moph.go.th Hetero Drugs Ltd: Mr M. Srinivas Reddy Director International Marketing Hetero House H.No. 8-3-166/7/1 Erragadda, Hyderabad - 500 018 India Tel: +91 40 23704923/24/25 Tel (direct): +91 40 2381 8029 Fax: +91 40 23704926 Cell: +91 40 9848019440 Email: msreddy@heterodrugs.com contact@heterodrugs.com Merck & Co. Inc: Dr Jeffrey L. Sturchio Vice President, External Affairs Human Health Europe, Middle East & Africa Merck & Co. Inc/WS2A-55 One Merck Drive

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Whitehouse Station NJ 08889-0100 USA Tel: +1 908 423 39 81 Fax: +1 908 735 1839 Email: jeffrey_sturchio@merck.com Ranbaxy: Mr. Sandeep Juneja Ranbaxy Laboratories Limited Tel: + 91 11 2600 2120 (Direct) or + 91 11 2645 2666-72 Fax: + 91 11 2600 2121 Email: sandeep.juneja@ranbaxy.com www.aidonaids.com Roche: For information regarding quotations and deliveries to customers contact: Hanspeter Walchli Logistics Sales International Customers Dept. PTBS-IM 4070 Basel / Switzerland Tel: +41 61 688 1060 Fax: +41 61 687 1815 Email: hanspeter.waelchli@roche.com Strides Arcolab Ltd: Mrs. Aloka Sengupta Business Head ATM Strides House, Bilekahalli Bannerghatta Road Bangalore 560 076, INDIA Tel: 91-80-6581343/44/46 Fax: 91-80-6583538/6584330 Email id: aloka@stridesarco.com

Glossary [11]

3TC lamivudine; nucleoside analogue reverse transcriptase Inhibitor AAI United Nations Accelerating Access Initiative; Accelerated Access emerged out of the partnership initiated in May 2000 between the UN (UNFPA, UNICEF, WHO, the World Bank and UNAIDS Secretariat) and five pharmaceutical companies (Boehringer-Ingelheim GmbH, Bristol-Myers Squibb, GlaxoSmithKline, Merck & Co., Inc., and F. Hoffmann-La Roche Ltd (Roche); Abbott Laboratories Ltd. joined the initiative later) to increase access to HIV/AIDS care, treatment and support. AAI plays a role in facilitating price negotiations between developing country governments and ‘originator’ drug companies that are participating in the AAI. ABC abacavir; nucleoside analogue reverse transcriptase inhibitor AIDS Acquired Immune Deficiency Syndrome

CIF[9] ‘Cost Insurance and Freight’ means that the seller delivers when the goods pass the ship’s rail in the port of shipment. The seller must pay the costs and freight necessary to bring the goods to the named port of destination BUT the risk of loss or damage to the goods, as well as any additional costs due to events occurring after the time of delivery, are transferred from the seller to the buyer. CIP[9] ‘Carriage and Insurance paid to...’ means that the seller delivers the goods to the carrier nominated by him but the seller must in addition pay the cost of carriage necessary to bring the goods to the named destination. This means that the buyer bears all the risks and any additional costs occurring after the goods have been so delivered. However, in CIP the seller also has to procure insurance against the buyer’s risk of loss of or damage to the goods during the carriage. Consequently, the seller contracts for insurance and pays the insurance premium. d4T stavudine; nucleoside analogue reverse transcriptase inhibitor

ARVs Antiretroviral drugs BMS Bristol-Myers Squibb CDC Centres for Disease Control and Prevention

ddI didanosine; nucleoside analogue reverse transcriptase inhibitor

DDU[9] ‘Delivered duty unpaid’ means that the seller delivers the goods to the buyer, not cleared for import, and not unloaded from any arriving means of transport at the named place of destination. The seller has to bear the costs and risks involved in bringing the goods thereto, other than, where applicable, any ‘duty’ (which term includes the responsibility for the risks of the carrying out of the customs formalities, and the payment of formalities, customs duties, taxes and other charges) for import in the country of destination. Such ‘duty’ has to be borne by the buyer as well as any costs and risks caused by his failure to clear the goods for the import time. EML Essential Medicines List. First published by WHO in 1977, it is meant to identify a list of medicines, which provide safe and effective treatment for the infectious and chronic diseases, which affect the vast majority of the world’s population. The 12th Updated List was published in April 2002 and includes 12 antiretrovirals. EFV or EFZ efavirenz; nonnucleoside analogue reverse transcriptase inhibitor EXW[9] ‘Ex-works’ means that the

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seller delivers when he places the goods at the disposal of the buyer at the seller’s premises or another named place (i.e. works, factory, warehouse etc.) not cleared for export and not loaded on any collecting vehicle. FOB[9] ‘Free on board’ means that the seller delivers when the goods pass the ship’s rail at the named port of shipment. This means that the buyer has to bear all costs and risks of loss or damage to the goods from that point. The FOB term requires the seller to clear the goods for export. Generic drug According to WHO, a pharmaceutical product usually intended to be interchangeable with the innovator product, which is usually manufactured without a license from the innovator company. Generic products may be marketed either under a non-proprietary or approved name rather than a proprietary name. GPO Governmental Pharmaceutical Organization (Thailand) GSK GlaxoSmithKline HIV Human Immunodeficiency Virus

IDV indinavir; protease inhibitor LDCs Least Developed Countries, according to United Nations classification MSD Merck Sharp & Dome (Merck & Co., Inc.) MSF Médecins Sans Frontières NGO Non Governmental Organization NFV nelfinavir; protease inhibitor NNRTI Non-Nucleoside Reverse Transcriptase Inhibitor NRTI Nucleoside Analogue Reverse Transcriptase Inhibitor

TDF tenofovir; nucleotide reverse transcriptase inhibitor UNAIDS United Nations Joint Cosponsored Programme on HIV/AIDS, created in 1996, to lead, strengthen and support an expanded response to the HIV/AIDS epidemic. The six original Cosponsors are UNICEF, UNDP, UNFPA, UNESCO, WHO and the World Bank. UNDCP joined in April 1999 UNDP United Nations Development Programme WHO World Health Organization ZDV zidovudine; nucleoside analogue reverse transcriptase inhibitor

NtRTI Nucleotide Reverse Transcriptase Inhibitor NVP nevirapine; non-nucleoside analogue reverse transcriptase inhibitor PMTCT Prevention of Mother-To-Child Transmission r ritonavir, low dose ritonavir used as a booster; protease inhibitor SQV hgc saquinavir hard gel capsules; protease inhibitor

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References

[1] Accessing ARVs: “Untangling the Web of Price Reductions for Developing Countries”, first edition October 2001, second edition June 2002, third edition December 2002, and fourth edition May 2003. [2] Pilot Procurement, Quality and Sourcing Project: “Access to HIV/AIDS drugs and diagnostics of acceptable quality”, Eleventh edition 1st December 2003. http://mednet3.who.int/prequal/hiv/hi v-suppliers.doc [3] “Sources and prices of selected drugs and diagnostics for people living with HIV/AIDS”. A joint UNICEF, UNAIDS Secretariat, WHO, MSF project. May 2003 (WHO/EDM/PAR/2003.2). http://www.who.int/medicines/organiz ation/par/ipc/sources-prices.pdf [4] Other generic manufacturers known to be producing one or more ARVs but not included in this document are: Richmond Laboratorios, Panalab, Filaxis (Argentina); Pharmaquick (Benin); Far Manguinhos, FURP, Lapefe, Laob, Iquego, IVB (Brazil); Apotex, Novopharm (Canada); Shanghai Desano Biopharmaceutical company, Northeast General Pharmaceutical Factory (China); Biogen (Colombia); Stein (Costa Rica); Zydus Cadila

Healthcare, SunPharma, EAS-SURG, Mac Leods, IPCA (India); Cosmos (Kenya); LG Chemicals, Samchully, Korea United Pharm Inc. (Korea); Protein, Pisa (Mexico); Andromaco (Spain); Aspen (South Africa); T.O. Chemecal (Thailand); Laboratorio Dosa S.A. (US), Varichem (Zimbabwe). This list is not exhaustive. [5] “Scaling-up Antiretroviral therapy in Resource Limited Settings: Guidelines for a Public Health approach”, June 2002. http://www.who.int/hiv/pub/prev_care/ en/ScalingUp_E.pdf New edition will be available soon.

[9] Incoterms 2000 http://www.iccwbo.org/index_incoterm s.asp [10] To find the HIV prevalence status of countries see http://www.who.int/hiv/pub/epidemiol ogy/pubfacts/en/ [11] Abbreviations for the ARVs are taken from the WHO draft guidelines “Scaling-up Antiretroviral therapy in Resource Limited Settings: Guidelines for a Public Health approach”, June 2002 http://www.who.int/hiv/pub/prev_care/ en/ScalingUp_E.pdf

[6] “Guidelines for the Use of Antiretroviral Agents in HIV-1Infected Adults and Adolescents”, by the Panel on Clinical Practices for the Treatment of HIV, July 2003 (for those products not recommended in the WHO Guidelines). http://aidsinfo.nih.gov/guidelines/adul t/AA_071403.pdf [7] “Patent Situation of HIV/AIDS related drugs in 80 countries”, WHO/UNAIDS, 2000 http://who.int/medicines/library/par/hi vrelateddocs/patentshivdrugs.pdf [8] http://www.accessmedmsf.org/documents/patents_2003.pdf

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price

pr ice eligi bility

y n a p Untangling the web of price reductions: m o price c co un trie s a pricing guide for the purchase of ARVs for developing countries e i s r t n u o c

reductions redu c tions

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